The Role of Gut and Skin Microbiota in Alopecia Areata

The Role of Gut and Skin Microbiota in Alopecia Areata

The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) works to treat alopecia areata in adults. It will also learn about the safety of FMT. The main questions it aims to answer are:

• Can FMT cause hair regrowth?
• Can FMT modulate immune response? Researchers will compare FMT to a placebo (a look-alike substance that contains no drug) to see if FMT works to treat alopecia areata.

Participants will:

• Take FMT or a placebo for three consecutive days
• Follow-up evaluations will be performed at weeks 12, 24, and 48, with repeat clinical scoring, photodocumentation, microbiome analyses, laboratory testing, and quality-of-life assessment.

Inclusion Criteria:

1. Adults aged 18-65 diagnosed with Alopecia Areata (patchy or extensive) up to 10 years
2. Willingness to adhere to study protocols, including FMT administration via capsules or colonoscopy.
3. Ability to sign informed consent.
4. SALT score≥ 20

Exclusion Criteria:

1. History of gastrointestinal disorders (e.g., IBD, celiac disease).
2. Recent use of antibiotics, probiotics, or prebiotics (within 2 months).
3. Pregnant or breastfeeding women of childbearing potential who are unwilling or unable to use an acceptable method of birth control.
4. Individuals with immunocompromised or immunosuppressed states (e.g., HIV, cancer).
5. Prior FMT treatment for any condition.
6. Therapy with new antidepressants or had a change in antidepressant dose within previous 3 months
7. Serious medical comorbidities(including neurological or phychiatric comorbidities)
8. Elevated C-reactive protein concentration, abnormal baseline laboratory tests
9. Severe(anaphylactic) food allergy
10. Concomitant treatments for AA: topical KS 1 week prior to randomization, topical JAK inhibitor, diphenylcyclopropenone, or other topical immunotherapies within 4 weeks prior to randomization;systemic corticosterids, immunosuppressant, intra-lesional or intra-articular corticosteroid injections, or oral JAK inhibitor within 8 weeks prior to randomization;monoclonal antibody <5 half-lives prior to randomization; probenecid at the time of randomization. Bimatoprost ophtalmic solution was allowed if on stable dose for 8 weeks.